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Understanding of Biosimilars Law Expected to Be Slow, Gradual Process

Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...

By John T. Aquino

Nov. 16 — The life
sciences industry's understanding of the biosimilar statute will
evolve gradually through a series of court decisions over time,
panelist said Nov. 16 at a biotech intellectual property
conference.

This will be frustrating to the makers of
biosimilars and to patients, all of whom want similar and less
expensive versions of biologics that treat cancers and other
diseases quickly approved for market, as well as to the makers of
the original biologics who want to protect their patent rights, the
panelists said.

Panelists said that everyone is searching for
certainty from a statute they described as “fractured.”

Shaping Biologic Litigation for
Decades

The focus of the panel's discussion was on the
decision by the U.S. Court of Appeals for the Federal Circuit in
Amgen v. Sandoz (9 LSLR 828, 7/24/15).
In that case, a three-judge panel offered a split decision,
affirming in part and denying in part the district court's
interpretation of the Biologics Price Competition and Innovation
Act (BPCIA), which offers a streamlined approval process for
biosimilars.

In Amgen, the Federal
Circuit denied each parties' petition for a hearing of the full (en
banc) court on Oct. 16 (9 LSLR 1199, 10/30/15), and a petition for
Supreme Court review must be received by Jan. 14, 2016, the
panelists said.

“The ultimate outcome—whether the parties appeal to
the Supreme Court and the court grants certiorari [review] or the
court or the parties decide to let the Federal Circuit's ruling
stand—will determine how biosimilar litigation proceeds for decades
to come,” said Lisa Barons Pensabene, head of life sciences
litigation at O'Melveny & Myers, LLP.

For now, applicants for approval will pick pieces of
the BPCIA that suit them in an effort to get the biosimilar
approved and to market quickly, she said.

The session, titled the “Evolving Landscape of
Biosimilars Litigation in the United States,” was held at the BIO
IP Counsels Committee Conference in Cary, N.C.

The Food and Drug Administration defines a
biosimilar as a biologic product that is approved based on a
showing that it is highly similar to an already-approved biological
product, known as a reference product. The applicant relies on the
reference product sponsors' (RPS's) data as part of the BPCIA's
abbreviated approval pathway. The FDA approved the first
biosimilar, known as Zarxio and made by Sandoz, in March, as a
biosimilar of Amgen's cancer treatment Neupogen (9 LSLR 328,
3/20/15).

BPCIA: Three Judges, Three
Interpretations

Zarxio was the focus of Amgen's litigation against
Sandoz, with Amgen arguing that the BPCIA requires Sandoz to give
to Amgen Zarxio's abbreviated biologic application (aBLA), Amgen
and Sandoz to agree on a list of patents owned or licensed by Amgen
that might be infringed by Zarxio, and Sandoz to provide Amgen with
180 days' notice that it planned to market a biosimilar. Sandoz
contended that the exchange of information was optional, not
mandatory, and that the 180-day notice could start from the date
Sandoz filed the aBLA rather than the date the FDA approved Zarxio
for market.

The Federal Circuit agreed with Sandoz and the
district court that the information exchange outlined in the BPCIA
is optional and with Amgen that the 180-day notice can only begin
once the FDA has approved the biosimilar. “The court said that you
can only declare your intent to market what you have received
approval to market,” Pensabene said.

“But it's important to know that three different
judges presented three different interpretations of the BPCIA, with
Judge Raymond T. Chen disagreeing with Judges Pauline Newman and
Alan D. Lourie, arguing that the notice of commercial marketing is
not a stand-alone,” she said.

Certainty From Supreme
Court?

“What was Judge Lourie trying to do with majority
opinion? He said the same thing as BIO's amicus brief, which was
that the case was all about notice,” Pensabene indicated, referring
to the brief filed by the Biotechnology Industry Organization,
which sponsored the BIO IP conference. “Lourie's opinion says that
providing the aBLA is optional, but that if you don't do that there
is a stand-alone requirement of 180 days' notice so that the RPS
has notice prior to the biosimilar's launch.”

Timothy Creagan, chief patent counsel for Sanofi's
Genzyme, said, “If the Supreme Court views the exchange of
information in the BPCIA as optional, like the Federal Circuit and
district court did, that would be unfavorable to the life sciences
industry. How can you decide whether a biosimilar infringes your
patent if you don't have access to the aBLA and its manufacturing
information and you don't have a patent discussion with the
applicant? And the 180-day notice portion of the Federal Circuit's
decision has been viewed as adding six months of exclusivity for
the RPS, which some have described as a ‘windfall.' I hope the case
doesn't go to the Supreme Court because the idea of a ‘windfall'
for biopharmas would not be well received by the court.”

Immac J. Thampoe, managing IP counsel of biologics
and vaccines for Merck & Co., disagreed. “There are policy
reasons to make medicines accessible to patients, and many big
pharmas have invested in biosimilars and are looking for certainty.
It's important that we know the rules of the game, for the
companies and for patients. Therefore, I think it will be a good
thing for it to go to the Supreme Court because we will have some
clarity.”

Creagan said, “I'm all for certainty if we get the
right result.”

Picking Pieces From the
BPCIA

Pensabene said, “People ask, why are we in this
mess? It's because the drafters of the BPCIA were thinking of a
world in which exclusivity remains for patents and there would be
an orderly process performed by the parties of exchanging
information against a backdrop of the very generous 12-year
exclusivity which the BPCIA gives to the RPS. But this is not the
case for many, many drugs. None of the drugs currently in
litigation have any exclusivity left. Sandoz filed its application
and was faced with a period of information exchange while it was
chafing at the bit to get to market.”

There are more than 55 biologic products with a date
of licensure of 2007 or earlier, which means that their exclusivity
expires in 2019, Pensabene added. “This is a problem for now. The
Supreme Court, if it takes the issue up, is going to have to make a
decision based on a fact pattern that won't exist in 10
years.”

Pensabene described the near future as “a BPCIA-ish
world, with applicants picking pieces of BPCIA to hand over,
turning over lists of patents to the RPS and saying, ‘Go on and sue
me for infringement based on the list if you can, but we have met
most of the requirements of the BPCIA and therefore don't have to
give you 180-days notice.' This has some appeal. An RPS will have a
list of patents the biosimilar could infringe, and if a patent is
not on list, the RPS can never assert infringement of that patent.
The question is, if an applicant does this, does it have to provide
the 180[-days'] notice? Judge Chen said the 180-days' notice isn't
a stand-alone provision, and Lourie writing in the majority opinion
said that in this case it was. More clarity is needed on
this.”

Piecemeal, Very Slow
Process

“Apotex is following the BPCIA's information
exchange for its biosimilars of Amgen's Neulasta and Neupogen,” he
said (9 LSLR 1143, 10/16/15). “It gave notice early and said we
don't have to give notice at all because we followed the BPCIA and
are stopping at the notice. The new strategy is trying to get
around giving the six-month's notice,” Prugo said.

Pensabene said, “Each new case will give us a little
bit more information about how to work this statute.”

Prugo said, “It's a piecemeal, very slow buildup
about what the BPCIA requires.”

To contact the reporter on this story: John T.
Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story:
Nancy Simmons at nsimmons@bna.com

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